Identity
- Trade Name
- PlumePen FDA UDI
- Generic Name
- Open-surgery electrosurgical handpiece/electrode, monopolar, single-use FDA UDI
- Device Name
- PlumePen Pro Surgical Smoke Evacuation Pencil, 7/8" (22 mm), 15 ft. (4.6 m) FDA UDI
- Model / Reference
- PLPRO4520 FDA UDI
- Description
- PlumePen Pro Surgical Smoke Evacuation Pencil, 7/8" (22 mm), 15 ft. (4.6 m) FDA UDI
Identifiers
- Catalog Number
- PLPRO4520 FDA UDI
- Primary DI / UDI-DI
- 20845854061203 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Open-surgery electrosurgical handpiece/electrode, monopolar, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Dimensions & Sizes
- Size
- Length — 15 Feet FDA UDILength — 4.6 Meter FDA UDIOuter Diameter — 22 Millimeter FDA UDIOuter Diameter — 0.875 Inch FDA UDI
Category: Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
PlumePen by Conmed Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Conmed Corporation
Sources (1)
- FDA UDI 6c899300-7f0c-46b8-94c4-552bf36d7ebe 37 fields · synced Jun 8, 2026